LogoFDA 510(k) Search
K Number
K130210
Device Name
MEDELA THOPAZ
Manufacturer
MEDELA AG
Date Cleared
2013-03-15

(45 days)

Product Code
BTA
Regulation Number
878.4780
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
K043140,K080212
Predicate For
K141553
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.

Device Description

Powered Suction Pump

AI/ML Overview

The provided text is a 510(k) summary for the Medela® THOPAZ Suction Pump. It asserts substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with performance metrics.

Instead, it states:

  • "The Medela® THOPAZ Suction Pump is equipped with the identical technology like other marketed devices. These technological features do not affect safety and effectiveness of the device or the application (pleural and mediastinal drainage)."
  • "There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (pleural and mediastinal drainage)."
  • "The Medela® THOPAZ suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices."

Therefore, I cannot populate the requested table or answer most of the questions because the document explicitly states the device is identical in technology and performance to predicate devices (K080212 and K043140) and does not present new performance data or studies to demonstrate meeting acceptance criteria.

The submission is based on the premise that since it's identical to already-cleared devices, new performance studies are not required.

Given the information provided, the following elements cannot be extracted:

  • A table of acceptance criteria and the reported device performance: Not provided; the device is stated to be identical to predicates.
  • Sample size used for the test set and the data provenance: Not applicable as no new performance study is detailed.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  • Adjudication method: Not applicable.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  • The type of ground truth used: Not applicable.
  • The sample size for the training set: Not applicable.
  • How the ground truth for the training set was established: Not applicable.

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.